We know the language of medtech companies. ISS AG takes into account the customer’s strategic objectives as well as any operational, ethical, regulatory and statistical requirements. ISS services begin with a first strategic design and extends to the final clinical investigation report. Our service attitude includes high quality, flexibility, cost effectiveness and speed. Clinical investigations include feasibility or pilot investigations, confirmatory clinical investigations for CE certification or post market investigations. We also offer legal representation of foreign sponsors in Switzerland and Europe.
Clinical Project Management
A clinical project manager or service specialist is specifically chosen and assign to each of our customers based on the requiremnents and the specialist’s experience. The assigned clinical project manager is the key contact for our customer and for all parties involved in the clinical project. The primary role of our clinical project manager is to successfully complete a clinical investigation project within agreed timelines and budget. Additional keys to success are a proactive attitude along with a well documented communication trail that permits a constant flow of information to the customer.
Clinical Investigation Planning
Our internal experts’ abilities include coordination and design of new Clinical Investigations according to sponsor and experts input in the field with various objectives (HTA, FDA, Health Economics and therapeutic areas).
Medical writing of essential documents needed for a successful submission at the ethics and competent authorities. Writing of documents includes Investigator Brochure, Clinical Investigation Plan CIP according to ISO 14155, Patient Informed Consent, the final Clinical Report as well as other possibilities.
Our in-house Regulatory Affairs specialists will provide all necessary support to submit the required documentation as well as any follow-up meetings with Ethics Committees or other regulatory authorities. We provide all necessary support in obtaining positive Ethics Committee and Authority approval before the clinical investigation begins.
We also offer gap analysis of the technical documentation and the compiling of documents for Investigation submissions.
All clinical project monitoring is done according to EN ISO 14155 (including risk-based monitoring). Our Monitors or Clinical Research Associates (CRA) actively participate in the clinical investigation from the site selection, study initiation, routine and regular monitoring to the completion of project. ISS associates routinely assess the compliance of study sites with current regulatory requirements according to Declaration of Helsinki and EN ISO 14155, the Clinical Investigation Plan, the correct use of the Medical Device and the correctness of the data obtained. ISS continually supports the study site with respect to all open issues around the clinical investigation.
ISS AG has built up an own network of clinical operations specialist throughout Europe. In following countries we have selected CRAs at our services: Germany, Austria, Switzerland, France, Spain, Italy, Belgium Netherlands, UK, and Hungary. With selected partner CROs, ISS AG may offer also clinical operation services in USA and Near East.
Depending on your needs we have good contacts into other countries and can facilitate your planned clinical project in other countries of the world.
Statistics and Data Management
ISS AG has the statistical expertise to correctly plan, analyze and report the data for a clinical investigation. We offer a wide range of statistical and data management options that include descriptive analysis to complex adaptive clinical investigation designs.
Validated statistical programs in compliance with regulatory guidelines (R, JMP) are commonly used and the level of sophistication is selected per the sensitivity of each investigation.
We provide Data Management expertise from CRF design to collecting, cleaning and integrating clinical data.
Post Market Clinical Follow-Up Studies (PMCF)
Under the new Medical Device Regulation (MDR) and new Guidelines, more PMCF-studies to confirm the safety and effectiveness of a medical device are requested by Notified Bodies.
The ISS AG is an audited Clinical Research Organization (CRO), which has successfully carried out PMCF-studies.
Revision 4 of the guideline MEDDEV 2.7/1, which has been in effect since June 2016, significantly restricts the scope for the creation of clinical evaluations, especially with regards to the use of data of other products and the justification for the waiver of clinical data for one’s own product. It also further specifies the requirements concerning the qualification of the authors of an evaluation. With a well-developed team in place, ISS now offers state of the art clinical evaluations according to MEDDEV 2.7/1.
Through our support you win time and assurance in your clinical evaluations. In addition, our process for the creation of a clinical evaluation offers you several options when defining the scope of work.
Creation of a clinical evaluation in several steps
MEDDEV. 2.7/1 Rev. 4 defines the clinical evaluation as a process in 5 phases (stages 0 through 4). Our approach and the associated templates are based on this phase model. We carry out the projects in phases in order to detect risks and weak data material early and to take appropriate measures. In stage 0, we work closely with the knowledge carriers of your company. Depending on the agreement, you have the possibility to conduct reviews in the following stages.
Clinical evaluation as a process according to MEDDEV. 2.7/1 Rev. 4
The aim of our according to Rev. 4 newly designed and modular creation process is to correctly and efficiently incorporate your expertise, the product history and technical details into the clinical evaluation in collaboration with you. Depending on the situation, individual sections can be provided by you.
Why choose ISS for clinical evaluations?
Our team currently consists of four scientists (PhD) and ten engineers. With its expertise in research techniques and biostatistics as well as the experience from more than 60 evaluations, which have been found compliant by various Notified Bodies, it meets the high requirements of Rev. 4 with respect to the authors of clinical evaluations. Since the introduction of the new MEDDEV 2.7/1 revision 4 guideline, ISS AG has written more than 50 clinical evaluations.
We have a network of specialists from various disciplines. Currently we can cover the following medical specializations with our own medical experts: ophthalmology, odontology, traumatology, and orthopedics. We seek expert advice from other disciplines on a situational basis.
Thanks to our proximity to IT issues and software development, we can support the process with tools that ensure high efficiency in the creation of an evaluation.